Posted to MedZilla HealthCare on 10/23/2018


Takeda Pharmaceuticals

US-MA, Staff Engineer, Device Development R0003413-MZ


 
 

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Staff Engineer, Device Development in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Staff Engineer working on the Device Development team, you will be empowered to build relationships with internal and external stakeholders and influence multiple areas of the device development process.

POSITION ACCOUNTABILITIES:

  • Manage the design and development of medical devices and combination products for Takeda pipeline.
  • Work with cross functional stakeholders to determine device requirements and oversee design, testing, and manufacturing of devices and combination products at external partners.
  • Lead teams to evaluate and select appropriate device technologies for Takeda s pipeline assets
  • Build and maintain relationships with key vendors and assists with technical aspects of vendor negotiations
  • Represent device development function at CMC and other cross functional teams and plans resources to execute specific project tasks.
  • Plans and implements resolutions to technical problems/issues
  • Monitor device competitive landscape and update development plans accordingly
  • Provide input on device packaging, labeling, and instructions for use
  • Manage preparation of device for human factors and market research studies
  • Oversee the GMP production of clinical devices at external partners

EDUCATION, EXPERIENCE AND SKILLS:

  • Degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related fields:
    • BS/BA Degree with 8+ years relevant industry experience
    • MS/MA Degree with 6+ years relevant industry experience
    • PhD with 1+ relevant industry experience
  • Experience in developing combination drug delivery devices under Design Control (21CFR820) and ISO 14791 requirements
  • Experience with human factor studies
  • Experience managing external design, development and cGMP manufacturing partners
  • Strong technical leadership and communications skills

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Please visit our website at takedajobs.com

 
 


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